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A 4-week Study Investigating Two Targeted Brightening Serum (A and B) Versus 4% Hydroquinone in Women With Mild to Severe Full-face Hyperpigmentation

8 de junio de 2026 actualizado por: Revision Skincare

A Multi-Center, Randomized, Blinded, Split-Face, Controlled Clinical Study to Assess Two Targeted Brightening Serum (A and B) Paired With 4% Hydroquinone

This a short four-week pilot study to measure the efficacy and tolerance of two brightening serums (cosmetics) versus 4% hydroquinone. The study was conducted in two sites across the USA, one in PA and in one in CA. The goal was to run the pilot study in the summer to understand the role of these two potential brightening serums in helping the appearance of skin tone evenness.

Descripción general del estudio

Descripción detallada

This is a four-week multi-center, single-blind, randomized, split-face, controlled pilot study conducted to assess the efficacy and tolerance of two pigment correction formulations (Brightening Serum A and Brightening Serum B) compared to 4% Hydroquinone split face when used over the course of 4 weeks by healthy females with clinically determined mild to severe facial hyperpigmentation, including melasma on the global face. Subjects will be randomized into 2 cells which will receive the following split face treatments:

  • Cell 1: Brightening Serum A versus 4% Hydroquinone
  • Cell 2: Brightening Serum B versus 4% Hydroquinone It was hypothesized that the Brightening Serum A and B will produce statistically significant improvements at post-baseline timepoints when compared with baseline, and comparable improvements versus the standard of care 4% Hydroquinone across the primary endpoint, secondary and tertiary endpoints. Additionally, the Sponsor's test materials will be well tolerated by subjects, with no statistically significant increases in scores for tolerability/safety parameters, specifically erythema and dryness, at any study timepoint when compared with baseline scores. Furthermore, the Sponsor's test materials will be well perceived by subjects according to analyses of self-assessment questionnaires, with a statistically significant proportion of favorable responses compared to unfavorable responses and/or a statistically significant improvement in subject response values when compared with baseline.

Tipo de estudio

Intervencionista

Inscripción (Actual)

18

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Texas
      • Irving, Texas, Estados Unidos, 75063
        • Revision Skincare

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Descripción

Inclusion Criteria:

  • In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
  • Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type)
  • Age 20 to 60 years.
  • Subjects with self-perceived hyperpigmented facial skin
  • Having mild to severe (score of 3-9 according to a modified Griffiths scale,2 where 0 = none, 1 to 3 = mild, 4 to 6 = moderate, 7 to 9 = severe) full-face hyperpigmentation, including melasma. Hyperpigmentation and melasma must present at equal severity and size on each facial side.
  • Willing to maintain visit 1/baseline condition of eyebrows and eyelashes (do not noticeably change brow/lash appearance) during the study.
  • Willing to provide written informed consent and able to read, speak, write, and understand English.
  • Willing to sign a photography release.
  • Having not had any facial treatments in the past 6 months and are willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox®), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin. Waxing and threading are allowed but not facial laser hair removal.

Exclusion Criteria:

  • Having been diagnosed with known allergies to skin care products.
  • Having a known reactivity to tranexamic acid, niacinamide, sunflower seed, coconut, rosemary, barley, goji, sandalwood, licorice root, radish root, beeswax, yeast, ascorbic acid, tetrahexyldecyl ascorbate, and/or any of the ingredients in the study products.
  • Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
  • Having a history of skin cancer within the past 5 years.
  • Currently taking oral or topical prescription medications for melasma such as Triluma, compounded hydroquinone, retinoids, and tranexamic acid.
  • Currently using oral or topical prescription medications for acne such as doxycycline, minocycline, clindamycin, bactrim, tetracycline, erythromycin, vibramycin, azelaic acid, benzoyl peroxide, Dapsone, or sodium sulfacetamide.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Brightening Serum A
The brightening serum A is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamoyl Dipeptide-23, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
Comparador activo: Brightening Serum B
The brightening serum B is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamic acid, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
Otro: 4% Hydroquinone
This topical 4% hydroquinone cream was applied split-face to side randomized for application.
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Measurement of Clinical Efficacy Parameters by Clinical Grader
Periodo de tiempo: Baseline, week 2, week 4
Clinical grading efficacy parameters measured by blinded clinical grader including skin tone evenness, hyperpigmentation on the global face, and overall appearance. Grading was performed on a 10-point Griffith's scale, where 0 = best possible outcome 9= severe skin condition. A decrease in score/ value indicates an improvement.
Baseline, week 2, week 4

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Measurement of Global Melasma Severity Assessment Score (GMSA)
Periodo de tiempo: baseline and weeks 2 and 4

The expert grader (Board-Certified Dermatologist) will evaluate the right and left facial side using a Global Melasma Severity Assessment (GMSA) according to the following numerical definitions. Half-point scores may be used as necessary to more accurately describe the skin condition.

0 = clear

  1. = mild
  2. = moderate
  3. = severe
baseline and weeks 2 and 4

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Measurement of facial Melasma
Periodo de tiempo: Baseline, week 2 and week 4
The MASI score is a clinical tool used to assess the severity of melasma, a hyperpigmentation disorder, in terms of both area and darkness. It quantifies the extent and intensity of melasma in four facial regions: the forehead (F), right malar region (MR), left malar region (ML), and chin (C), corresponding to 30%, 30%, 30%, and 10% of the total face, respectively. A decrease in score indicates improvement
Baseline, week 2 and week 4
Incidence of Treatment- Emergent Adverse Events
Periodo de tiempo: Baseline, week 2, and week 4
Local cutaneous tolerability was evaluated by assessing the signs and symptoms of the following objective and subjective irritation parameters globally on each subject's face. Objective irritation (clinically graded): erythema, edema, and dryness. Subjective irritation (assessed by subjects): burning, stinging, and itching. Local cutaneous tolerability was evaluated by assessing objective (erythema, edema, and dryness) and subjective (burning, stinging, and itching) irritation parameters globally on each subject's face using a 4-point scale (0 = none to 3 = severe). A decrease in value indicates an improvement.
Baseline, week 2, and week 4

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de agosto de 2025

Finalización primaria (Actual)

12 de noviembre de 2025

Finalización del estudio (Actual)

12 de noviembre de 2025

Fechas de registro del estudio

Enviado por primera vez

3 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de junio de 2026

Publicado por primera vez (Actual)

12 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 07242025
  • Revision Skincare, LLC (Otro número de subvención/financiamiento: Revision Skincare, LLC)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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